The study evaluating the effect of probiotic supplementation on the mental status, inflammation, and intestinal barrier in major depressive disorder patients using gluten-free or gluten-containing diet (SANGUT study): a 12-week, randomized, double-blind, and placebo-controlled clinical study protocol
Abstract Background Current treatment of major depressive disorder (MDD) often does not achieve full remission of symptoms. Therefore, new forms of treatment and/or adjunct therapy are needed. Evidence has confirmed the modulation of the gut–brain–microbiota axis as a promising approach in MDD patie...
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| Format: | Article |
| Language: | English |
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BMC
2019-08-01
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| Series: | Nutrition Journal |
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| Online Access: | http://link.springer.com/article/10.1186/s12937-019-0475-x |
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| author | Hanna Karakula-Juchnowicz Joanna Rog Dariusz Juchnowicz Igor Łoniewski Karolina Skonieczna-Żydecka Paweł Krukow Malgorzata Futyma-Jedrzejewska Mariusz Kaczmarczyk |
| author_facet | Hanna Karakula-Juchnowicz Joanna Rog Dariusz Juchnowicz Igor Łoniewski Karolina Skonieczna-Żydecka Paweł Krukow Malgorzata Futyma-Jedrzejewska Mariusz Kaczmarczyk |
| author_sort | Hanna Karakula-Juchnowicz |
| collection | DOAJ |
| description | Abstract Background Current treatment of major depressive disorder (MDD) often does not achieve full remission of symptoms. Therefore, new forms of treatment and/or adjunct therapy are needed. Evidence has confirmed the modulation of the gut–brain–microbiota axis as a promising approach in MDD patients. The overall purpose of the SANGUT study—a 12-week, randomized, double-blind, and placebo-controlled Study Evaluating the Effect of Probiotic Supplementation on the Mental Status, Inflammation, and Intestinal Barrier in Major Depressive Disorder Patients Using Gluten-free or Gluten-containing Diet — is to determine the effect of interventions focused on the gut-brain-microbiota axis in a group of MDD patients. Methods A total of 120 outpatients will be equally allocated into one of four groups: (1) probiotic supplementation+gluten-free diet group (PRO-GFD), (2) placebo supplementation+ gluten-free diet group (PLA-GFD), (3) probiotic supplementation+ gluten containing diet group (PRO-GD), and (4) placebo supplementation+gluten containing diet group (PLA-GD). PRO groups will receive a mixture of psychobiotics (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175), and GFD groups will follow a gluten-free diet. The intervention will last 12 weeks. The primary outcome measure is change in wellbeing, whereas the secondary outcome measures include physiological parameters. Discussion Microbiota and its metabolites have the potential to influence CNS function. Probiotics may restore the eubiosis within the gut while a gluten-free diet, via changes in the microbiota profile and modulation of intestinal permeability, may alter the activity of microbiota-gut-brain axis previously found to be associated with the pathophysiology of depression. It is also noteworthy that microbiota being able to digest gluten may play a role in formation of peptides with different immunogenic capacities. Thus, the combination of a gluten-free diet and probiotic supplementation may inhibit the immune-inflammatory cascade in MDD course and improve both psychiatric and gut barrier-associated traits. Trial registration NCT03877393. |
| first_indexed | 2024-12-11T15:06:20Z |
| format | Article |
| id | doaj.art-6c5ca941e08d448d88a65d1fa4d3051f |
| institution | Directory Open Access Journal |
| issn | 1475-2891 |
| language | English |
| last_indexed | 2024-12-11T15:06:20Z |
| publishDate | 2019-08-01 |
| publisher | BMC |
| record_format | Article |
| series | Nutrition Journal |
| spelling | doaj.art-6c5ca941e08d448d88a65d1fa4d3051f2022-12-22T01:00:54ZengBMCNutrition Journal1475-28912019-08-0118111310.1186/s12937-019-0475-xThe study evaluating the effect of probiotic supplementation on the mental status, inflammation, and intestinal barrier in major depressive disorder patients using gluten-free or gluten-containing diet (SANGUT study): a 12-week, randomized, double-blind, and placebo-controlled clinical study protocolHanna Karakula-Juchnowicz0Joanna Rog1Dariusz Juchnowicz2Igor Łoniewski3Karolina Skonieczna-Żydecka4Paweł Krukow5Malgorzata Futyma-Jedrzejewska6Mariusz Kaczmarczyk71st Department of Psychiatry, Psychotherapy and Early Intervention, Medical University of Lublin1st Department of Psychiatry, Psychotherapy and Early Intervention, Medical University of LublinDepartment of Psychiatric Nursing, Medical University of LublinDepartment of Biochemistry and Human Nutrition, Pomeranian Medical UniversityDepartment of Biochemistry and Human Nutrition, Pomeranian Medical UniversityDepartment of Clinical Neuropsychiatry, Medical University of Lublin1st Department of Psychiatry, Psychotherapy and Early Intervention, Medical University of LublinDepartment of Clinical and Molecular Biochemistry, Pomeranian Medical UniversityAbstract Background Current treatment of major depressive disorder (MDD) often does not achieve full remission of symptoms. Therefore, new forms of treatment and/or adjunct therapy are needed. Evidence has confirmed the modulation of the gut–brain–microbiota axis as a promising approach in MDD patients. The overall purpose of the SANGUT study—a 12-week, randomized, double-blind, and placebo-controlled Study Evaluating the Effect of Probiotic Supplementation on the Mental Status, Inflammation, and Intestinal Barrier in Major Depressive Disorder Patients Using Gluten-free or Gluten-containing Diet — is to determine the effect of interventions focused on the gut-brain-microbiota axis in a group of MDD patients. Methods A total of 120 outpatients will be equally allocated into one of four groups: (1) probiotic supplementation+gluten-free diet group (PRO-GFD), (2) placebo supplementation+ gluten-free diet group (PLA-GFD), (3) probiotic supplementation+ gluten containing diet group (PRO-GD), and (4) placebo supplementation+gluten containing diet group (PLA-GD). PRO groups will receive a mixture of psychobiotics (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175), and GFD groups will follow a gluten-free diet. The intervention will last 12 weeks. The primary outcome measure is change in wellbeing, whereas the secondary outcome measures include physiological parameters. Discussion Microbiota and its metabolites have the potential to influence CNS function. Probiotics may restore the eubiosis within the gut while a gluten-free diet, via changes in the microbiota profile and modulation of intestinal permeability, may alter the activity of microbiota-gut-brain axis previously found to be associated with the pathophysiology of depression. It is also noteworthy that microbiota being able to digest gluten may play a role in formation of peptides with different immunogenic capacities. Thus, the combination of a gluten-free diet and probiotic supplementation may inhibit the immune-inflammatory cascade in MDD course and improve both psychiatric and gut barrier-associated traits. Trial registration NCT03877393.http://link.springer.com/article/10.1186/s12937-019-0475-xDepressionProbioticsGluten-free dietInflammationIntervention studyGut-brain axis |
| spellingShingle | Hanna Karakula-Juchnowicz Joanna Rog Dariusz Juchnowicz Igor Łoniewski Karolina Skonieczna-Żydecka Paweł Krukow Malgorzata Futyma-Jedrzejewska Mariusz Kaczmarczyk The study evaluating the effect of probiotic supplementation on the mental status, inflammation, and intestinal barrier in major depressive disorder patients using gluten-free or gluten-containing diet (SANGUT study): a 12-week, randomized, double-blind, and placebo-controlled clinical study protocol Nutrition Journal Depression Probiotics Gluten-free diet Inflammation Intervention study Gut-brain axis |
| title | The study evaluating the effect of probiotic supplementation on the mental status, inflammation, and intestinal barrier in major depressive disorder patients using gluten-free or gluten-containing diet (SANGUT study): a 12-week, randomized, double-blind, and placebo-controlled clinical study protocol |
| title_full | The study evaluating the effect of probiotic supplementation on the mental status, inflammation, and intestinal barrier in major depressive disorder patients using gluten-free or gluten-containing diet (SANGUT study): a 12-week, randomized, double-blind, and placebo-controlled clinical study protocol |
| title_fullStr | The study evaluating the effect of probiotic supplementation on the mental status, inflammation, and intestinal barrier in major depressive disorder patients using gluten-free or gluten-containing diet (SANGUT study): a 12-week, randomized, double-blind, and placebo-controlled clinical study protocol |
| title_full_unstemmed | The study evaluating the effect of probiotic supplementation on the mental status, inflammation, and intestinal barrier in major depressive disorder patients using gluten-free or gluten-containing diet (SANGUT study): a 12-week, randomized, double-blind, and placebo-controlled clinical study protocol |
| title_short | The study evaluating the effect of probiotic supplementation on the mental status, inflammation, and intestinal barrier in major depressive disorder patients using gluten-free or gluten-containing diet (SANGUT study): a 12-week, randomized, double-blind, and placebo-controlled clinical study protocol |
| title_sort | study evaluating the effect of probiotic supplementation on the mental status inflammation and intestinal barrier in major depressive disorder patients using gluten free or gluten containing diet sangut study a 12 week randomized double blind and placebo controlled clinical study protocol |
| topic | Depression Probiotics Gluten-free diet Inflammation Intervention study Gut-brain axis |
| url | http://link.springer.com/article/10.1186/s12937-019-0475-x |
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